RECRUITING

Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study

Conditions

Oligometastatic Prostate Carcinoma Prostate Adenocarcinoma Prostate Ductal Adenocarcinoma Prostate Intraductal Carcinoma Stage IVB Prostate Cancer AJCC v8

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial compares the usual treatment of radiation therapy alone to using the study drug, relugolix, plus the usual radiation therapy in patients with castration-sensitive prostate cancer that has spread to limited other parts of the body (oligometastatic). Relugolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of testosterone (a male hormone) produced by the body. It may stop the growth of cancer cells that need testosterone to grow. Radiation therapy uses high-energy x rays or protons to kill tumor cells. The addition of relugolix to the radiation may reduce the chance of oligometastatic prostate cancer spreading further.

Official Title

A Phase II Double-Blinded, Placebo-Controlled Trial of PROstate OligoMETastatic RadiotHErapy With or Without ANdrogen Deprivation Therapy in Oligometastatic Prostate Cancer (NRG Promethean)

Quick Facts

Study Start:2022-04-20

Study Completion:2029-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05053152

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Pathologically (histologically or cytologically) proven diagnosis of prostate adenocarcinoma at any anatomical location (for example, prostate, metastatic site), including intraductal or ductal carcinoma, at any time before registration * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 180 days prior to registration * Prior curative-intent treatment to the prostate, by either: * External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites * Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes * Must meet study entry criteria based on the following diagnostic workup within 120 days prior to registration: * History and physical examination; * Fluciclovine or PSMA PET scan (must be positive with exception of local disease); * PET must be combined with either CT or MRI, but a diagnostic CT or MRI reading/interpretation is not required * 1 - 5 oligometastatic lesions in bone and/or nodal/soft tissue sites on fluciclovine or PSMA PET within 180 days prior to registration and includes at least ONE of the following: * Bone - each metastasis is counted (for example, 2 distinct lesions in the right ilium count as 2 oligometastatic lesions) * Extrapelvic Nodal/ soft tissue - requires at least one extrapelvic inguinal or a nodal/soft tissue lesion superior to the iliac bifurcation (that is, American Joint Committee on Cancer \[AJCC\] M1a version 8) * Note: Although a patient must have bone and/or extrapelvic disease to be eligible, when counting the number of oligometastatic lesions, each lymph node lesion, whether pelvic or extrapelvic, is counted (for example, 2 distinct lymph nodes in the right external iliac basin count as 2 oligometastatic lesions; one extrapelvic and one pelvic node count as 2 oligometastic lesions, etc) * Serum total prostate-specific antigen (PSA) =\< 10.0 ng/mL that also meets ONE of the following PSA recurrence definitions: * PSA \>= post-radiation therapy (RT) nadir PSA + 2 ng/mL, obtained within 180 days prior to registration, if patient received-radiation therapy to intact prostate, or * Current PSA \>= 0.2 ng/mL, with a second confirmatory PSA \>= 0.2 ng/mL if patient received a radical prostatectomy with or without post-op RT. The initial PSA may be outside 180 days BUT the second confirmatory PSA must be within 180 days prior to registration, or * PSA \> 0.2 ng/mL with at least two rises from treatment nadir with the most recent PSA within 180 days prior to registration, if patient received radiation therapy to intact prostate * Must have \>= 3 PSA values within the last two years since end of primary treatment or within the last 2 years prior to registration, whichever is less * Note: PSA doubling time must be calculated by entering all PSA values since end of primary treatment or within the last 2 years prior to registration (whichever is less) into the PSA Doubling Time Calculator found at MDCalc.com * Serum total testosterone \>= 100 ng/dL within 180 days prior to registration * Note: Prior androgen deprivation therapy (other than bilateral orchiectomy) is allowed if discontinued prior to registration and serum total testosterone is \>= 100 ng/dL * Total bilirubin: =\< 1.5 x institutional upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, subject is eligible if direct bilirubin is =\< 1.5 x ULN) (within 180 days prior to registration) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]): =\< 2.5 x institutional ULN (within 180 days prior to registration) * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B) * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * The patient must agree to use a highly effective contraception (even men with vasectomies) if he is having sex with a woman of childbearing potential or with a woman who is pregnant while on study drug and for 2 weeks following the last dose of study drug * The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information	* Clinical, biopsy-proven, or radiologic (conventional or PET imaging) evidence of local tumor recurrence in the prostate and/or periprostatic/seminal vesicle region after radiotherapy, or in the prostate bed after prostatectomy * Note: if a patient had a prior local recurrence and received local salvage therapy, the patient is eligible if there is no current evidence of disease in the prostate/prostate bed. Patients with positive findings on examination or imaging remain eligible if biopsy of the site is negative for cancer. Patients who have a positive PET scan in the prostate or prostate bed and have undergone local therapy since PET but prior to enrollment to NRG-GU011 are eligible without a repeat PET scan * Currently on androgen deprivation or anti-androgen therapy * Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis * Note: Spinal metastases (PET-detected) with epidural extension are eligible if there is \> 0.3 cm spatial separation between the gross tumor volume and spinal cord * Biopsy-proven prostatic carcinoma with signet-ring, sarcomatoid, or neuroendocrine features (for example, small cell) * Prior metastatic or non-metastatic, invasive malignancy (except non metastatic, non-melanomatous skin cancer) unless continuously disease free for \>= 3 years * Prior chemotherapy for prostate cancer or bilateral orchiectomy * Note: Prior chemotherapy for a different cancer is allowed if continuously disease-free for \>= 3 years * Prior radiotherapy to a lesion (i.e. oligometastatic recurrence by PET) * Note: Lesions outside of a previously irradiated planning treatment volume (PTV) are eligible as long as the prescription isovolume dose of any prior radiotherapy course is \> 2.0 cm distant from new lesion * Inability to treat all oligometastatic sites with radiotherapy in the judgement of the investigator * Intrapelvic lymph nodes as only site of prostate cancer recurrence * Inability to swallow whole, undivided, unchewed, and uncrushed pills * Known gastrointestinal disorder affecting oral medication absorption * Co-morbidity defined as follows: * Patients with any comorbidities that would prohibit completion of protocol specified therapy * Inflammatory bowel disease in patients in whom abdominopelvic radiotherapy is planned * History of congenital long QT syndrome * Current severe or unstable angina * New York Heart Association functional classification III/IV heart failure (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification)

Inclusion Criteria

Exclusion Criteria

* Pathologically (histologically or cytologically) proven diagnosis of prostate adenocarcinoma at any anatomical location (for example, prostate, metastatic site), including intraductal or ductal carcinoma, at any time before registration
* Age \>= 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 180 days prior to registration
* Prior curative-intent treatment to the prostate, by either:
* External beam and/or brachytherapy to: Prostate alone, prostate and seminal vesicles, prostate and pelvic nodes, or radiation to all three sites
* Radical prostatectomy alone, radical prostatectomy plus postoperative radiotherapy to the prostate bed, or radical prostatectomy plus postoperative radiotherapy to the pelvic nodes
* Must meet study entry criteria based on the following diagnostic workup within 120 days prior to registration:
* History and physical examination;
* Fluciclovine or PSMA PET scan (must be positive with exception of local disease);
* PET must be combined with either CT or MRI, but a diagnostic CT or MRI reading/interpretation is not required
* 1 - 5 oligometastatic lesions in bone and/or nodal/soft tissue sites on fluciclovine or PSMA PET within 180 days prior to registration and includes at least ONE of the following:
* Bone - each metastasis is counted (for example, 2 distinct lesions in the right ilium count as 2 oligometastatic lesions)
* Extrapelvic Nodal/ soft tissue - requires at least one extrapelvic inguinal or a nodal/soft tissue lesion superior to the iliac bifurcation (that is, American Joint Committee on Cancer \[AJCC\] M1a version 8)
* Note: Although a patient must have bone and/or extrapelvic disease to be eligible, when counting the number of oligometastatic lesions, each lymph node lesion, whether pelvic or extrapelvic, is counted (for example, 2 distinct lymph nodes in the right external iliac basin count as 2 oligometastatic lesions; one extrapelvic and one pelvic node count as 2 oligometastic lesions, etc)
* Serum total prostate-specific antigen (PSA) =\< 10.0 ng/mL that also meets ONE of the following PSA recurrence definitions:
* PSA \>= post-radiation therapy (RT) nadir PSA + 2 ng/mL, obtained within 180 days prior to registration, if patient received-radiation therapy to intact prostate, or
* Current PSA \>= 0.2 ng/mL, with a second confirmatory PSA \>= 0.2 ng/mL if patient received a radical prostatectomy with or without post-op RT. The initial PSA may be outside 180 days BUT the second confirmatory PSA must be within 180 days prior to registration, or
* PSA \> 0.2 ng/mL with at least two rises from treatment nadir with the most recent PSA within 180 days prior to registration, if patient received radiation therapy to intact prostate
* Must have \>= 3 PSA values within the last two years since end of primary treatment or within the last 2 years prior to registration, whichever is less
* Note: PSA doubling time must be calculated by entering all PSA values since end of primary treatment or within the last 2 years prior to registration (whichever is less) into the PSA Doubling Time Calculator found at MDCalc.com
* Serum total testosterone \>= 100 ng/dL within 180 days prior to registration
* Note: Prior androgen deprivation therapy (other than bilateral orchiectomy) is allowed if discontinued prior to registration and serum total testosterone is \>= 100 ng/dL
* Total bilirubin: =\< 1.5 x institutional upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, subject is eligible if direct bilirubin is =\< 1.5 x ULN) (within 180 days prior to registration)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]): =\< 2.5 x institutional ULN (within 180 days prior to registration)
* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
* Note: Known positive test for hepatitis B virus surface antigen (HBV sAg) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy. Patients who are immune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g. patients immunized against hepatitis B)
* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
* Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection would make the patient ineligible unless the viral load becomes undetectable on suppressive therapy
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* The patient must agree to use a highly effective contraception (even men with vasectomies) if he is having sex with a woman of childbearing potential or with a woman who is pregnant while on study drug and for 2 weeks following the last dose of study drug
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information

* Clinical, biopsy-proven, or radiologic (conventional or PET imaging) evidence of local tumor recurrence in the prostate and/or periprostatic/seminal vesicle region after radiotherapy, or in the prostate bed after prostatectomy
* Note: if a patient had a prior local recurrence and received local salvage therapy, the patient is eligible if there is no current evidence of disease in the prostate/prostate bed. Patients with positive findings on examination or imaging remain eligible if biopsy of the site is negative for cancer. Patients who have a positive PET scan in the prostate or prostate bed and have undergone local therapy since PET but prior to enrollment to NRG-GU011 are eligible without a repeat PET scan
* Currently on androgen deprivation or anti-androgen therapy
* Spinal cord compression, or spinal intramedullary, brain, and/or visceral (for example liver, lung, etc.) metastasis
* Note: Spinal metastases (PET-detected) with epidural extension are eligible if there is \> 0.3 cm spatial separation between the gross tumor volume and spinal cord
* Biopsy-proven prostatic carcinoma with signet-ring, sarcomatoid, or neuroendocrine features (for example, small cell)
* Prior metastatic or non-metastatic, invasive malignancy (except non metastatic, non-melanomatous skin cancer) unless continuously disease free for \>= 3 years
* Prior chemotherapy for prostate cancer or bilateral orchiectomy
* Note: Prior chemotherapy for a different cancer is allowed if continuously disease-free for \>= 3 years
* Prior radiotherapy to a lesion (i.e. oligometastatic recurrence by PET)
* Note: Lesions outside of a previously irradiated planning treatment volume (PTV) are eligible as long as the prescription isovolume dose of any prior radiotherapy course is \> 2.0 cm distant from new lesion
* Inability to treat all oligometastatic sites with radiotherapy in the judgement of the investigator
* Intrapelvic lymph nodes as only site of prostate cancer recurrence
* Inability to swallow whole, undivided, unchewed, and uncrushed pills
* Known gastrointestinal disorder affecting oral medication absorption
* Co-morbidity defined as follows:
* Patients with any comorbidities that would prohibit completion of protocol specified therapy
* Inflammatory bowel disease in patients in whom abdominopelvic radiotherapy is planned
* History of congenital long QT syndrome
* Current severe or unstable angina
* New York Heart Association functional classification III/IV heart failure (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association functional classification)

Contacts and Locations

Principal Investigator

Bridget F Koontz

PRINCIPAL_INVESTIGATOR

NRG Oncology

Study Locations (Sites)

Cancer Center at Saint Joseph's

Phoenix, Arizona, 85004

United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, 94704

United States

Tower Cancer Research Foundation

Beverly Hills, California, 90211

United States

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612

United States

Los Angeles General Medical Center

Los Angeles, California, 90033

United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033

United States

Cedars Sinai Medical Center

Los Angeles, California, 90048

United States

Memorial Medical Center

Modesto, California, 95355

United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868

United States

Sutter Pacific Medical Foundation

Santa Rosa, California, 95403

United States

Sutter Solano Medical Center/Cancer Center

Vallejo, California, 94589

United States

UCHealth University of Colorado Hospital

Aurora, Colorado, 80045

United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, 80304

United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909

United States

Memorial Hospital North

Colorado Springs, Colorado, 80920

United States

Shaw Cancer Center

Edwards, Colorado, 81632

United States

Poudre Valley Hospital

Fort Collins, Colorado, 80524

United States

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, 80528

United States

Banner North Colorado Medical Center

Greeley, Colorado, 80631

United States

UCHealth Greeley Hospital

Greeley, Colorado, 80631

United States

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, 80129

United States

Medical Center of the Rockies

Loveland, Colorado, 80538

United States

Banner McKee Medical Center

Loveland, Colorado, 80539

United States

Beebe South Coastal Health Campus

Millville, Delaware, 19967

United States

Helen F Graham Cancer Center

Newark, Delaware, 19713

United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713

United States

Beebe Health Campus

Rehoboth Beach, Delaware, 19971

United States

George Washington University Medical Center

Washington, District of Columbia, 20037

United States

Jupiter Medical Center

Jupiter, Florida, 33458

United States

GenesisCare USA - Lakewood Ranch

Lakewood Ranch, Florida, 34202

United States

AdventHealth Orlando

Orlando, Florida, 32803

United States

GenesisCare USA - Plantation

Plantation, Florida, 33324

United States

Moffitt Cancer Center-International Plaza

Tampa, Florida, 33607

United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Grady Health System

Atlanta, Georgia, 30303

United States

Emory University Hospital Midtown

Atlanta, Georgia, 30308

United States

Piedmont Hospital

Atlanta, Georgia, 30309

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342

United States

Piedmont Fayette Hospital

Fayetteville, Georgia, 30214

United States

Emory Johns Creek Hospital

Johns Creek, Georgia, 30097

United States

Advocate Good Shepherd Hospital

Barrington, Illinois, 60010

United States

Advocate Illinois Masonic Medical Center

Chicago, Illinois, 60657

United States

AMG Crystal Lake - Oncology

Crystal Lake, Illinois, 60014

United States

Carle at The Riverfront

Danville, Illinois, 61832

United States

Decatur Memorial Hospital

Decatur, Illinois, 62526

United States

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Advocate Sherman Hospital

Elgin, Illinois, 60123

United States

Advocate South Suburban Hospital

Hazel Crest, Illinois, 60429

United States

AMG Libertyville - Oncology

Libertyville, Illinois, 60048

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, 61938

United States

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, 62269

United States

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453-2699

United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068

United States

Methodist Medical Center of Illinois

Peoria, Illinois, 61636

United States

OSF Saint Francis Medical Center

Peoria, Illinois, 61637

United States

Memorial Hospital East

Shiloh, Illinois, 62269

United States

Springfield Memorial Hospital

Springfield, Illinois, 62781

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

Parkview Regional Medical Center

Fort Wayne, Indiana, 46845

United States

Goshen Center for Cancer Care

Goshen, Indiana, 46526

United States

Mary Greeley Medical Center

Ames, Iowa, 50010

United States

McFarland Clinic - Ames

Ames, Iowa, 50010

United States

Iowa Methodist Medical Center

Des Moines, Iowa, 50309

United States

Mission Cancer and Blood - Des Moines

Des Moines, Iowa, 50309

United States

The James Graham Brown Cancer Center at University of Louisville

Louisville, Kentucky, 40202

United States

UofL Health Medical Center Northeast

Louisville, Kentucky, 40245

United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, 70809

United States

Mary Bird Perkins Cancer Center - Metairie

Metairie, Louisiana, 70002

United States

East Jefferson General Hospital

Metairie, Louisiana, 70006

United States

LSU Healthcare Network / Metairie Multi-Specialty Clinic

Metairie, Louisiana, 70006

United States

University Medical Center New Orleans

New Orleans, Louisiana, 70112

United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

United States

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114

United States

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114

United States

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188

United States

Trinity Health Medical Center - Canton

Canton, Michigan, 48188

United States

Chelsea Hospital

Chelsea, Michigan, 48118

United States

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118

United States

Michigan Healthcare Professionals Clarkston

Clarkston, Michigan, 48346

United States

Michigan Healthcare Professionals Farmington

Farmington Hills, Michigan, 48334

United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, 49503

United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503

United States

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007

United States

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912

United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

United States

Michigan Healthcare Professionals Macomb

Macomb, Michigan, 48044

United States

Michigan Healthcare Professionals Madison Heights

Madison Heights, Michigan, 48071

United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341

United States

Corewell Health William Beaumont University Hospital

Royal Oak, Michigan, 48073

United States

Munson Medical Center

Traverse City, Michigan, 49684

United States

Corewell Health Beaumont Troy Hospital

Troy, Michigan, 48085

United States

Michigan Healthcare Professionals Troy

Troy, Michigan, 48098

United States

University of Michigan Health - West

Wyoming, Michigan, 49519

United States

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197

United States

Regions Hospital

Saint Paul, Minnesota, 55101

United States

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141

United States

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, 65401

United States

Washington University School of Medicine

Saint Louis, Missouri, 63110

United States

Siteman Cancer Center-South County

Saint Louis, Missouri, 63129

United States

Siteman Cancer Center at Christian Hospital

Saint Louis, Missouri, 63136

United States

Siteman Cancer Center at Saint Peters Hospital

Saint Peters, Missouri, 63376

United States

Benefis Sletten Cancer Institute

Great Falls, Montana, 59405

United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, 03756

United States

The Valley Hospital - Luckow Pavilion

Paramus, New Jersey, 07652

United States

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Highland Hospital

Rochester, New York, 14620

United States

University of Rochester

Rochester, New York, 14642

United States

Wilmot Cancer Institute at Webster

Webster, New York, 14580

United States

East Carolina University

Greenville, North Carolina, 27834

United States

Sanford Broadway Medical Center

Fargo, North Dakota, 58122

United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, 58122

United States

UH Seidman Cancer Center at UH Avon Health Center

Avon, Ohio, 44011

United States

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, 44122

United States

Miami Valley Hospital South

Centerville, Ohio, 45459

United States

Case Western Reserve University

Cleveland, Ohio, 44106

United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

Miami Valley Hospital

Dayton, Ohio, 45409

United States

Premier Blood and Cancer Center

Dayton, Ohio, 45409

United States

Miami Valley Hospital North

Dayton, Ohio, 45415

United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066

United States

UH Seidman Cancer Center at Lake Health Mentor Campus

Mentor, Ohio, 44060

United States

University Hospitals Parma Medical Center

Parma, Ohio, 44129

United States

University Hospitals Portage Medical Center

Ravenna, Ohio, 44266

United States

ProMedica Flower Hospital

Sylvania, Ohio, 43560

United States

Upper Valley Medical Center

Troy, Ohio, 45373

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Oregon Health and Science University

Portland, Oregon, 97239

United States

UPMC Altoona

Altoona, Pennsylvania, 16601

United States

UPMC-Heritage Valley Health System Beaver

Beaver, Pennsylvania, 15009

United States

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, 19010

United States

Carlisle Regional Cancer Center

Carlisle, Pennsylvania, 17015

United States

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, 19317

United States

Chambersburg Hospital

Chambersburg, Pennsylvania, 17201

United States

Geisinger Medical Center

Danville, Pennsylvania, 17822

United States

Fox Chase Cancer Center - East Norriton Hospital Outpatient Center

East Norriton, Pennsylvania, 19401

United States

Ephrata Cancer Center

Ephrata, Pennsylvania, 17522

United States

UPMC Hillman Cancer Center Erie

Erie, Pennsylvania, 16505

United States

UPMC Cancer Center at UPMC Horizon

Farrell, Pennsylvania, 16121

United States

Fox Chase Cancer Center Buckingham

Furlong, Pennsylvania, 18925

United States

Adams Cancer Center

Gettysburg, Pennsylvania, 17325

United States

UPMC Pinnacle Cancer Center/Community Osteopathic Campus

Harrisburg, Pennsylvania, 17109

United States

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033-0850

United States

IRMC Cancer Center

Indiana, Pennsylvania, 15701

United States

Sechler Family Cancer Center

Lebanon, Pennsylvania, 17042

United States

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, 17837

United States

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Mechanicsburg, Pennsylvania, 17050

United States

Riddle Memorial Hospital

Media, Pennsylvania, 19063

United States

UPMC Hillman Cancer Center in Coraopolis

Moon, Pennsylvania, 15108

United States

Paoli Memorial Hospital

Paoli, Pennsylvania, 19301

United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

UPMC-Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213

United States

UPMC-Saint Margaret

Pittsburgh, Pennsylvania, 15215

United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232

United States

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, 15232

United States

UPMC-Passavant Hospital

Pittsburgh, Pennsylvania, 15237

United States

Geisinger Cancer Services-Pottsville

Pottsville, Pennsylvania, 17901

United States

UPMC Cancer Center at UPMC Northwest

Seneca, Pennsylvania, 16346

United States

UPMC Washington Hospital Radiation Oncology

Washington, Pennsylvania, 15301

United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, 18711

United States

Divine Providence Hospital

Williamsport, Pennsylvania, 17754

United States

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096

United States

WellSpan Health-York Cancer Center

York, Pennsylvania, 17403

United States

UPMC Memorial

York, Pennsylvania, 17408

United States

Carolina Regional Cancer Center

Myrtle Beach, South Carolina, 29577

United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, 57104

United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, 57117-5134

United States

Covenant Medical Center-Lakeside

Lubbock, Texas, 79410

United States

Dartmouth Cancer Center - North

Saint Johnsbury, Vermont, 05819

United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, 23235

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298

United States

VCU Community Memorial Health Center

South Hill, Virginia, 23970

United States

FHCC at EvergreenHealth

Kirkland, Washington, 98034

United States

Fred Hutchinson Cancer Center

Seattle, Washington, 98109

United States

FHCC at Northwest Hospital

Seattle, Washington, 98133

United States

University of Washington Medical Center - Montlake

Seattle, Washington, 98195

United States

Edwards Comprehensive Cancer Center

Huntington, West Virginia, 25701

United States

Langlade Hospital and Cancer Center

Antigo, Wisconsin, 54409

United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701

United States

Aurora Cancer Care-Grafton

Grafton, Wisconsin, 53024

United States

Aurora BayCare Medical Center

Green Bay, Wisconsin, 54311

United States

Aurora Bay Area Medical Group-Marinette

Marinette, Wisconsin, 54143

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

United States

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051

United States

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, 53215

United States

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Aurora Sinai Medical Center

Milwaukee, Wisconsin, 53233

United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548

United States

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, 53149

United States

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017

United States

Drexel Town Square Health Center

Oak Creek, Wisconsin, 53154

United States

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, 53066

United States

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, 54904

United States

Aspirus Cancer Care - James Beck Cancer Center

Rhinelander, Wisconsin, 54501

United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868

United States

Vince Lombardi Cancer Clinic-Sheboygan

Sheboygan, Wisconsin, 53081

United States

Aspirus Cancer Care - Stevens Point

Stevens Point, Wisconsin, 54481

United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482

United States

Aurora Medical Center in Summit

Summit, Wisconsin, 53066

United States

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, 53188

United States

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401

United States

Aurora Cancer Care-Milwaukee West

Wauwatosa, Wisconsin, 53226

United States

Aurora West Allis Medical Center

West Allis, Wisconsin, 53227

United States

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095

United States

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476

United States

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494

United States

Collaborators and Investigators

Sponsor: NRG Oncology

Bridget F Koontz, PRINCIPAL_INVESTIGATOR, NRG Oncology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-20

Study Completion Date2029-02-01

Study Record Updates

Study Start Date2022-04-20

Study Completion Date2029-02-01

Terms related to this study

Additional Relevant MeSH Terms

Oligometastatic Prostate Carcinoma
Prostate Adenocarcinoma
Prostate Ductal Adenocarcinoma
Prostate Intraductal Carcinoma
Stage IVB Prostate Cancer AJCC v8